“One area of important medical innovation is the generation and use of data. This is not just hype around ‘big data’ but the recognition that we need amalgamation of data streams that tell the whole person’s story. This includes information about the cancer itself, and also the individual’s personal life: their values and needs, their personal experiences, as well as biometric monitoring. The longitudinal story expressed through data can then be used to support many innovations in cancer care. It can act as a clinical annotation stream to inform biological research such as annotation of biospecimens, biomarkers and basic discovery. It can be used to optimize cancer care delivery, or used for quality monitoring and to highlight gaps in care to be resolved. It can be used to compare differing interventions to figure out what works for whom and when. Advancing high quality and sustainable medical care is dependent on innovations around the generation and use of data.”

………………

Newton F. Crenshaw, Vice President, North American Oncology Commercial Operations, Global Business Development and Advocacy, Eli Lilly and Company

“Medical innovation is absolutely central to advancing the fight against the over 200 types of cancer. Each new advance, no matter how small, contributes to our scientific understanding of this collection of diseases, and provides new hope and cures to people with cancer. This cycle of continuous innovation has had impressive results and generated savings throughout the health care system: since 1975, the 5-year survival rate for cancer patients has increased by about 40%. To sustain–and accelerate–this progress, our society must continue to foster and reward innovation.”

………………

Tony Coelho, Former Member, U.S. House of Representatives; Chairman, Partnership to Improve Patient Care

“The rapid pace of medical innovation in oncology is increasing our ability to provide more personalized, patient-centered care (based on their biomarkers, quality of life considerations, etc.). Achieving more efficient delivery of high quality care will require continued medical innovation, including development of new treatments, improvements to existing treatments, and increasing efficiencies in the delivery system that support higher quality care and an overall a reduction in the economic and health burden of disease. But innovation is worthless without access to it.”

Great stories are published daily about the impact personalized medicine is having on individual patients, and the medical community as a whole, but it can be a challenge to stay on top of the news. With that in mind, we bring to you a monthly roundup of the three to five most thought-provoking articles we are reading, sharing and discussing with our colleagues.

Michael Kattan, chairman of the department of quantitative health sciences at Cleveland Clinic’s Lerner Research Institute, discusses sophisticated risk calculators, or “nomograms,” that can combine a patient’s unique characteristics, such as age, gender, race, extent and type of disease and other health factors; compare them with the vast databases of similar cases and studies; and use them to predict probable outcomes depending on the treatment a patient chooses.

On September 9, the House Energy and Commerce Committee’s Subcommittee on Health held a hearing to examine the regulation of laboratory developed tests (LDTs) as a continuation of the committee’s 21st Century Cures initiative. Members heard testimonies from various witnesses on recently released guidance from the U.S. Food and Drug Administration (FDA) and its impact on innovation and the practice of precision medicine. Read more about the FDA’s proposed framework for regulating LDTs.

The United States is in potential danger of losing its biomedical edge to countries that are aggressively funding research into personalized medicine, according to discussion that emerged at the 21st Century Cures Roundtable on September 5. Roundtable panelists noted that biotechnology is at a crossroads in America, and that funding levels for research have flattened in recent years.

Mary-Claire King, the geneticist who identified the first breast cancer gene, is recommending that all women get tested for genetic mutations that can cause breast cancer, regardless of their personal or family history. According to a paper she recently published in Proceedings of the National Academy of Science, women who carry mutations in BRCA1 or BRCA2, but have no family history of breast or ovarian cancer, have the same high risks of developing either cancer as those who are identified to be at-risk by virtue of their family history.